"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"

NCT ID: NCT06570746

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-25

Brief Summary

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"In our study, we aimed to compare the effects of conventional radiofrequency thermocoagulation applied to the articular branches of the femoral and obturator nerves with chemical ablation using phenol on hip pain."

Detailed Description

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"Our study is designed as a double-blind, prospective randomized controlled trial. Blinding will be ensured by keeping the researcher performing pain diary follow-ups unaware of which procedure was applied to each patient.

Patients will be randomized using computer-assisted methods. Following approval from the hospital ethics committee, clinical trial registration will be conducted. From 2024 to 2025, patients presenting with chronic hip pain to the Department of Algology at ADU Faculty of Medicine will be divided into two groups. In Group 1, chemical ablation of the femoral and obturator nerve branches with phenol under ultrasound guidance will be performed. In Group 2, conventional radiofrequency thermocoagulation of the articular branches of the femoral and obturator nerves under ultrasound guidance will be applied.

During the study, pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, 2 hours post-procedure, and at 1 month and 3 months post-procedure for both Group 1 and Group 2. The WOMAC scale will be used to evaluate their functional capacity."

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.

Group Type EXPERIMENTAL

Sedative

Intervention Type DRUG

Sedation is applied before the procedure

Chemical ablation with phenol

Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points. Before the procedure, the femoral artery was visualized with a linear ultrasound probe to prevent arterial injury by entering 2 cm lateral to the femoral artery. Following this, a mixture of 2.5 cc of 0.05% bupivacaine and 2.5 cc of 6% phenol was applied, and a lesion was created for 90 seconds at 80°.

Group Type ACTIVE_COMPARATOR

Sedative

Intervention Type DRUG

Sedation is applied before the procedure

Interventions

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Sedative

Sedation is applied before the procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Be older than 18 years old. Written consent must be obtained. Have had chronic hip pain for more than 3 weeks. -

Exclusion Criteria

Major psychiatric illness Presence of lumbar radicular pain or referred pain in the patient Patients using anticoagulant agents Patients with infection in the area where the procedure will be performed Those with allergy to local anesthetics Those allergic to phenol or betamethasone Pregnant women Scheduled for surgery

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Akylai Dosieva

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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akylai dosieva

Role: PRINCIPAL_INVESTIGATOR

Aydin Adnan Menderes University

Locations

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Adnan Menderes University Faculty of Medicine

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Akylai Dosieva, Resident doctor

Role: CONTACT

+905365088993

osman nuri aydın, Professor

Role: CONTACT

905325125124

Facility Contacts

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akylai dosieva

Role: primary

Other Identifiers

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2024

Identifier Type: -

Identifier Source: org_study_id

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